MAUDE Adverse Event Report: MAQUET SAS HLX 3000; LAMP, SURGICAL

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 20th december 2023 getinge became aware of an issue with one of our surgical lights ¿ hlx 3000.As it was stated, the label detached from fork during cleaning and disinfection.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ hlx 3000.As it was stated, the label detached from fork during cleaning and disinfection.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification due to detached label and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of torn or detached label, there is no event which led to the serious injury.Comparing the number of claimed devices to number of sold devices worldwide, we can state that the failure ratio for the issue of torn or detached label is very low.As stated by the subject matter expert at the manufacturing site, label peeling is probably due to collision or repeated excessive rubbing during cleaning of the device, the use of aggressive or unsuitable cleaning agents may be a contributing factor.The user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily checks (attachment 1 - hlx3000 ifu en 0132102 extract, page 22).To prevent any incident similar to the label missing, the user manual (attachment 1 - hlx3000 ifu en 0132102 extract, pages 19-20) mentions instructions concerning cleaning and disinfection, recommended and prohibited products.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: HLX 3000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18417786
• MDR Text Key: 331582990
• Report Number: 9710055-2023-00991
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1